Photobiomodulation for Breast Cancer Radiodermatitis

NCT04059809 | Completed Phase 2

• 1 other identifier: 2.777.676
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective single blind controlled randomized trial to evaluate the superiority of photobiomodulation (PBM) using LED-therapy in reducing the prevalence of radiodermatitis in breast cancer compared to usual local care.

Conditions

Breast Cancer; Radiodermatitis; Radiotherapy Side Effect; Radiation Dermatitis; Radiation Toxicity; Radiation Injuries; Quality of Life; Breast Neoplasms

Keywords

Laser; Photobiomodulation; Radiodermatitis; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Grade of Radiodermatitis

  "Radiation Therapy Oncology Group" (RTOG) grading

  During radiation treatment

• Grade of Radiodermatitis

  "Radiation Therapy Oncology Group" (RTOG) grading

  90 days after radiotherapy completion

Secondary Outcomes (8)

• Behavioral Risk Factor Surveillance

  One day after radiotherapy completion

• Behavioral Risk Factor Surveillance

  90 days after radiotherapy completion

• Arm Disabilities

  One day after radiotherapy completion

• Arm Disabilities

  90 days after radiotherapy completion

• Breast Cancer-Specific Quality of Life Questionnaire

  One day after radiotherapy completion

Study Arms (2)

Usual Care

NO INTERVENTION

The control group will have usual care according to the orientation of the radiation therapy faculty responsible for the radiotherapy treatment the PBM device will be switched off

Photobiomodulation (PBM)

EXPERIMENTAL

Additionally to the usual care, the patients will receive the PBM. Treatment will be done twice a week.

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

Photobiomodulation will be with the Cicatrillux (Cosmedical®) LED that contains 36 red light emitters in a 10x12 cm neoprene plate with 650 nm LED wave length whose optical spot diameter is 5 mm and with an average wave length of 2 \~ 5 mw for 10 minutes that will be placed over the area that will be irradiated for 10 minutes;

Photobiomodulation (PBM)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer
• Mastectomy or breast conserving surgery
• Informed consent
• Radiotherapy schedule completion

You may not qualify if:

• Auto-immune disorders
• Immediate reconstruction

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

Universidade do Vale do Itajai - UNIVALI

Itajaí, Santa Catarina, Brazil

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis; Radiation Injuries

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Glauco Baiocchi, MD, PhD

  AC Camargo Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participant and care provider will be blinded regarding the status of photobiomodulation device (if switched on or off).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized single blind controlled trial

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 16, 2019
• Study Start: September 26, 2018
• Primary Completion: July 20, 2021
• Study Completion: July 20, 2021
• Last Updated: August 13, 2021

Record last verified: 2021-07

Locations

BR (1)